Adelante Breezeway

GUDID 00885672000257

Delivery Sheath, 8F

Oscor Inc.

Vascular guide-catheter, single-use

• Primary Device ID: 00885672000257
• NIH Device Record Key: f13f96b3-0629-4cbf-9996-534ed8c4fbb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adelante Breezeway
• Version Model Number: AB081040GW
• Company DUNS: 101835833
• Company Name: Oscor Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com

Device Dimensions

• Lumen/Inner Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 2.9 Millimeter
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter
• Device Size Text, specify: 0
• Angle: 55 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 2.9 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885672000257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101497

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-23
• Device Publish Date: 2017-10-03

On-Brand Devices [Adelante Breezeway]

• 00885672103798: Delivery Sheath, 8F
• 00885672103781: Delivery Sheath, 8F
• 00885672101961: Delivery Sheath, 10F
• 00885672101954: Delivery Sheath, 10F
• 00885672101800: Delivery Sheath, 8F
• 00885672101794: Delivery Sheath, 8F
• 00885672101787: Delivery Sheath, 8F
• 00885672101770: Delivery Sheath, 8F
• 00885672101763: Delivery Sheath, 8F
• 00885672101756: Delivery Sheath, 8F
• 00885672101749: Delivery Sheath, 8F
• 00885672101732: Delivery Sheath, 8F
• 00885672101725: Delivery Sheath, 10F
• 00885672101718: Delivery Sheath, 10F
• 00885672101701: Delivery Sheath, 10F
• 00885672101695: Delivery Sheath, 10F
• 00885672101688: Delivery Sheath, 10F
• 00885672101671: Delivery Sheath, 10F
• 00885672101664: Delivery Sheath, 10F
• 00885672101657: Delivery Sheath, 10F
• 00885672007102: Delivery Sheath, 10F
• 00885672006204: Delivery Sheath, 6F
• 00885672004965: Delivery Sheath, 7F
• 00885672004958: Delivery Sheath, 7F
• 00885672004941: Delivery Sheath, 7F
• 00885672004934: Delivery Sheath, 7F
• 00885672004927: Delivery Sheath, 7F
• 00885672004910: Delivery Sheath, 7F
• 00885672004903: Delivery Sheath, 7F
• 00885672004897: Delivery Sheath, 7F
• 00885672004880: Delivery Sheath, 6F
• 00885672004873: Delivery Sheath, 6F
• 00885672004866: Delivery Sheath, 6F
• 00885672004859: Delivery Sheath, 6F
• 00885672004842: Delivery Sheath, 6F
• 00885672004835: Delivery Sheath, 6F
• 00885672004828: Delivery Sheath, 6F
• 00885672004811: Delivery Sheath, 6F
• 00885672004477: Delivery Sheath, 8F
• 00885672004460: Delivery Sheath, 8F
• 00885672004453: Delivery Sheath, 8F
• 00885672004446: Delivery Sheath, 8F
• 00885672004439: Delivery Sheath, 8F
• 00885672004330: Delivery Sheath, 8F
• 00885672000325: Delivery Sheath, 8F
• 00885672000318: Delivery Sheath, 8F
• 00885672000301: Delivery Sheath, 8F
• 00885672000295: Delivery Sheath, 8F
• 00885672000288: Delivery Sheath, 8F
• 00885672000271: Delivery Sheath, 8F